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Specialist, Regulatory Affairs (Temporary Position)

As Regulatory Affairs Specialist, you will be responsible for lifecycle management of products manufactured at Orifarm’s own manufacturing sites. Therefore, you will collaborate closely with colleagues across functions, such as chemists, formulation specialists and co-workers within Quality, Supply Chain, Manufacturing and Sales.

Further, your main responsibilities include to:

• Gather information and documentation for variation applications
• Update dossier sections

Senior Specialist til QC hos Xellia Pharmaceuticals

Drømmer du om mere ansvar, med forskelligartede opgaver, og har du en passion for mikrobiologi? Vil du spille en central rolle i Xellias produktionen af livsvigtig antibiotika?

Som senior specialist vil du blive faglig ansvarlig for vores count release-laboratorie, som bl.a. udfører TVC- og LAL-analyser. Derudover vil du indgå i tæt samarbejde med vores sterile produktioner angående EM, hvor de nye Annex 1-krav stiller øgede krav til vores compliance, som du vil spille en vigtig rolle i.

Senior Medical Writer

Do you want to work in a global context and according to the highest standards of current practice to provide new products to patients with unmet medical needs?

As a Senior Medical Writer, you will be responsible for delivering submission-ready documents and take the role as lead medical writer on specific assignments. In addition, you can look forward to joining a diverse organisation shaped by cross-functional and global collaboration – and a focus on continuous transformation to support the future needs of clinical development.

Department Manager for Molecular Pharmacology

Gubra is seeking a dedicated and experienced Department Manager to lead our Molecular Pharmacology department. The ideal candidate will possess proven leadership abilities and a passion for managing and developing teams, along with a background in molecular pharmacology and drug discovery.

Your tasks include

• Daily management of a team of scientists and lab technicians to ensure high performance, personal development, well-being and engagement.
• Guide the team to accomplish department goals and objectives.
• Oversee the planning, execution, and analysis of experiments to support Gubra’s internal and partnered drug discovery projects.

QA Specialist og Senior QA Specialist

For dig, der trives med at arbejde med kvalitet og lovgivning fra et operationelt perspektiv, både selvstændigt og i dialog med vores leverandører og interne afdelinger.

Som QA Specialist vil du være det koordinerende bindeled mellem de forskellige teams i QA, regulatorisk og Pharmacovigilance i relation til udfærdigelse eller opdatering af eksisterende TA.

Continuous Improvement Partner

As a Continuous Improvement Partner in Drug Substance Manufacturing, you will be part of a team of Improvement Partners who develops and sustains systems and tools that enables the organization to consistently increase the level of operational excellence in manufacturing.

Your primary tasks will include but not be limited to:

• Develop and sustain CI systems and tools.
• Coach on ideal behaviour that drives a proactive improvement culture.

Senior Technical Writer - Regulatory (CMC)

You will join the Technical Writing team within Global Regulatory Affairs. We are responsible for global regulatory CMC writing of regulatory documents in applications for new approvals, worldwide market expansions, and product lifecycle activities. We work with a variety of pharmaceutical products, including small molecules, peptides, biologicals, recombinant products, and gene therapy.

Stepping into an informal and collaborative environment, you will have close interfaces with many different disciplines, including Global Pharmaceutical R&D, manufacturing sites, Product Supply, Quality Assurance, Ferring affiliates, and development sites around the world.

MS&T Program Manager

We are looking for an experienced professional from the pharmaceutical industry, who can effectively manage project plans across multiple entities and lead cross-functional processes within our own sites and supply chain.

As a MS&T Program Manager, you will be responsible for managing the projects, maintaining project databases, as well as ensuring effective communication and timely achievement of milestones.

Manufacturing Science & Technology (MS&T) Technical Transfer Project Manager (Sr Specialist)

Join Orifarm and take charge of building strong business relationships with a key portfolio of our suppliers!

As a MS&T Technical Transfer Project Manager, you will be responsible for securing technical support to Supplier Relationship Management functions, and manufacturing sites comprising support, technological transfers between CMOs and own manufacturing sites, analytical method development and validation, external product development at CDMOs and driving continuous technological improvement and innovation.

Protein Chemist for production of antibodies for cancer diagnostics

Do you find antibody production exciting?

You will play a key role in daily support of the production of conjugates. This can include:

• Support lab techs in case of technical issues with purification, conjugation, and test of antibodies.
• Handle compliance issues according to GMP standards.

We offer a high degree of freedom and development opportunities in an international company.